Zydus: Saroglitazar NDA for PBC Granted Priority Review by US FDA

Zydus Therapeutics, a subsidiary of Zydus Lifesciences, announced that the US FDA has granted Priority Review to its New Drug Application (NDA) for saroglitazar. The drug is intended for treating Primary Biliary Cholangitis (PBC) in adults, either in combination with ursodeoxycholic acid (UDCA) for those with inadequate response to UDCA, or as a monotherapy for patients unable to tolerate UDCA. The US FDA has set a PDUFA target action date of November 27, 2026.